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Beam is looking for a highly energetic Sr Manager/Associate Director, Manufacturing to join our growing Manufacturing team. The Sr Manager/Associate Director, Manufacturing will provide manufacturing operational and technical leadership throughout commercial ramp up and expansion. The candidate will participate in hiring and development of staff for the execution of manufacturing operations. This individual will be responsible for intially managing up to 16 direct labor manufacturing personnel for GMP production and lead a significant hiring ramp based on regulatory approvals. This individual will maintain comprehensive operating plans, procedures, systems, and training plans that are consistent with company objectives. The ideal candidate will be a seasoned leader with a demonstrated track record of building and managing high performing teams. They will also possess the ability to successfully interface with multidisciplinary teams and build strong cross-functional relationships.
Job Responsibility
Cultivate Beam’s culture and our values-driven organization focused on people
Execute against the mission, vision, and strategy for Beam internal cGMP Manufacturing
Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations
Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget
Champion development of a learning culture that embraces innovation and continuous improvement
Prepare and maintain departmental budget and workforce model in partnership with the Director of Manufacturing
Support establishment of long range and business continuity plans
Manage and support up to but not limited to multiple areas of GMP production as needed
Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions
Build collaborative and empowered teams that put patients first
Recruit, retain, and develop high-performing and diverse teams
Represent department during audits and regulatory inspections
Establish and maintain strong relationships at the site and cross-functionally
Assures alignment of internal manufacturing schedules with product supply forecasts and program timelines
Develops and maintains detailed manufacturing project plans, defines risks, and establishes contingency plans to ensure projects are delivered on time, within budget, and adhere to high quality standards
Support critical regulatory inspections, electronic batch records implementation, and all commercial expansion activities
Contributes to development and implementation of manufacturing documents (electronic batch records, procedures, and technical reports)
Assist with manufacturing deviation investigations and change controls / CAPAs
Support facility and equipment design and qualification for ability to meet commercialization and regulatory expectations
Ability to work onsite daily and after hours as required to support Beam clinical autologous team
Requirements
Bachelor’s degree preferably with a science or engineering focus and a minimum of 10 years of Manufacturing and Operations experience
At least 2 years experience leading and developing people in a GMP setting
Experience working cross-functionally building and maintaining strong relationships